Yes, it's true. Gateway Analytical has one of the fastest turnaround times in the industry.

Better results. Faster. As soon as your sample comes through the door, we spring into action to properly log it, store it, and notify the individual scientists that will be diligently working on your project. Then it's off to specialized sample preparation and analytical probing by our fleet of cutting edge instruments. You'll have data, interpretation, and solutions in no time.

Gateway Analytical has carefully assembled a diverse team of curious experts. When the other guys run away from difficult problems or second guess their approach, our scientists move in to take a closer look with a forensic-based framework. Our process is focused on outcomes and driven by experts that have seen it all. You bring challenges. We deliver creative solutions.

We're not just another analytical lab. Why not? We spent years building a leading position in the highly-regulated pharmaceutical industry. That means our facilities are FDA-inspected, cGMP certified, and maintain ISO 9001 (quality management) and ISO 17025 (testing and calibration) standards. Simply put, there's a high bar for quality in all our work that others just can't match.

We've ditched one-size-fits-all customer service for a more personal, collaborative approach.

When you need us, call us. We're always here to answer your questions. As our growing list of returning customers has learned, you'll get to know the individual scientists working with your team to deliver results. They're real people. Our innovative real-time collaboration technology even allows us to demonstrate results and provide updates -- live from the lab.

Medical Device Analysis Services From Gateway Analytical

We're experts in foreign particulate analysis and wear debris testing, which are among the most important experiments conducted during the rigorous testing of medical devices. Plus, we can help you to identify the conditions that led to the emergence of defects or the failure of a product.

Breadcrumb

Particle sizing, counting, and identification analysis provides a detailed accounting of foreign particulate matter present on or within a medical device.

The presence of foreign materials in pharmaceutical products and medical devices can impact the immediate and long-term safety of the product. However, these foreign particles are often below the size range that can be manually manipulated. Gateway Analytical utilizes specialized sample preparation techniques to collect foreign particulates from drug products and automated, high throughput techniques to accurately determine elemental, spectral, and morphological information.

Our particle sizing, counting, and identification services allow our customers to analyze large populations of particles down to submicron scales within a matter of hours. This automated service can be performed on organic, inorganic, and metallic materials.

More specifically, our experts use SPE-Raman to count and size particles as small as 2 microns, while automated SEM-EDS can find particles down to the submicron level. All data reported in size bins as requested by the customer. Additionally, we have the ability to build customer-specific reference databases to fast track sourcing and root cause analysis services.

Reach out to our technical experts and tell us how Gateway Analytical can deliver value for your R&D project.

Related Analytical Instrumentation & Techniques

Our expert scientists conduct various analytical techniques using cutting-edge spectroscopy instruments. We take a forensic approach to problem solving that ensures we see through complexity to arrive at timely and accurate solutions focused on outcomes for your team.

This analysis produces high magnification images with excellent resolution, and contrast based on chemical makeup. Additionally, EDS indicates which elements are present in the sample. The SEM is a microscope that focuses a beam of electrons onto a sample, causing the sample to emit three types of signals. The instrument has detectors that process the signals that are emitted from the sample: Backscatter electrons, Secondary electrons, and X-Rays. Gateway uses the SEM systems for:

HIAC

Gateway Analytical uses a HIAC Light Obscuration particle counter to count and size particles within a liquid matrix. We can enumerate and bin particles down to 2 microns. We analyze based on both compendial (such as USP <788> and <789>) and non-compendial methods.

Single Particle Explorer (SPE)

The Single Particle Explorer quickly determines the size, shape, count and chemical composition of large populations of particles. The system analyzes particles down to 2 microns in size. The system combines imaging and spectroscopy (Raman and/or LIBS – Laser Induced Breakdown Spectroscopy) to provide detailed and efficient particle characterization.

Raman Chemical Imaging (RCI)

Gateway Analytical uses a Falcon II to perform Raman Chemical Imaging. Chemical Imaging combines optical spectroscopy, microscopy and digital imaging to provide image contrast based on chemical structure and concentration. This methodology combines the power of visual perception with the objectivity of spectroscopy to make characterization intuitive. In addition to basic chemical imaging, we perform ISPS (Ingredient Specific Particle Sizing), agglomerate identification, and polymorph studies.